Teleflex Recalls Visistat Skin Staplers Due to Labeling Error
Teleflex Medical is recalling Visistat 35R Disposable Skin Staplers because some boxes are mislabeled as containing Wide devices when they contain Regular devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error regarding device width without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Teleflex Medical is recalling 3,594 units of the WECK Visistat 35R Disposable Skin Stapler, Reference 528135. The recall is due to a labeling error where some boxes are marked as containing Visistat Wide devices, but they actually contain Visistat Regular devices.
The affected products were distributed worldwide, including in the United States and internationally to Australia, Belgium, and France. The specific U.S. states listed include California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, New Jersey, New York, North Carolina, Ohio, Oregon, Rhode Island, Texas, Utah, and Virginia.
Healthcare providers and consumers should check their inventory for this specific product and reference number. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor.
The recalled product
- Product
- WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 3,594
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 73H1600207
Distribution
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